Morphine(MOP) Rapid Test
by VivaChek Biotech (Hangzhou) Co., Ltd.
Ref VDMO-U102, VDMO-U101Model VDMO
Active
CE IVDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-VDMO-U102JZ | Date4 Dec 2024 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/IVDD Active
Specification
- Model / Reference
- VDMO-U102, VDMO-U101, VDMO
- Primary DI / UDI-DI
- D-VDMO-U102JZ, D-VDMO-U101JX, 06937339207395
- Basic UDI-DI
- B-VDMO-U102JZ, B-VDMO-U101JX, B-06937339207395
- EMDN Code
- W0102160508 Opiates - rt & poc
- Device Class
- Class IVD General
- EU market of registration
- NetherlandsItaly
Manufacturer details
- EUDAMED SRN
- CN-MF-000012160
- Authorised representative
- Lotus NL B.V. NL-AR-000000121
Other devices from VivaChek Biotech (Hangzhou) Co., Ltd.
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Properties
Other properties (7)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No